Pesticide Use Enforcement Program Standards Compendium, Volume II – Data Cost-Sharing Regulations Replacement Pages

The Office of Administrative Law approved the amendment of Title 3, California Code of Regulations (3CCR) sections 6170 and 6310, and the adoption of 3CCR sections 6312 and 6314. These regulations, effective December 19, 2006 prescribe in detail the proceeding authorized by Food and Agricultural Code (FAC) section 12811.5 to resolve disputes over the terms and amount of data cost-sharing.

These new regulations are summarized below:

• Title 3, CCR section 6170, “Application” addresses the registration application process, including data submission
• Title 3, CCR section 6310 “Dispute Resolution Proceedings,” outlines specifics regarding dispute resolution
• Title 3, CCR section 6312 “Noncompliance Notification” identifies notification procedures to the Department of Pesticide Regulation (DPR) by data holders of an applicant´s failure to comply with FAC section 12811.5
• Title 3, CCR section 6314 “Determination” provides timelines for submission of evidence by parties to DPR, timelines for DPR to issue its findings, and when applicable cancel an applicant´s product registration.

Overview:

FAC section 12811.5 allows DPR to consider evaluations of all data (i.e. human health, environmental fate) it has on file, regardless of the data source.

Applicants to register new pesticide products, or to amend a currently registered pesticide product must submit data in support of a registration application. However, if an applicant relies upon another company’s data to support the applicant´s registration, the applicant may be required to make an offer to pay the data owner.

Title 3, CCR sections 6170 and 6310-6314 have been formatted for inclusion in the Pesticide Use Enforcement Program Standards Compendium, Volume II (Laws and Regulations). To access the officially maintained version of the regulations (3CCR), use the link found on DPR´s web site at: www.cdpr.ca.gov/docs/legbills/opramenu.htm

Enclosed are the text for the new regulations, an updated Table of Contents page, and a revised replacement page guide for updating your manual.

If you have any questions, please contact Rachel Kubiak, Registration Omsbudsman, at (916) 324-3939 or rkubiak@cdpr.ca.gov.

Sincerely,